Almonds, Gut Microbiome and Kids

NCT07636850 | Recruiting

• 1 other identifier: STUDY00007355
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This 8-week parallel-arm randomized controlled trial (N=70; ages 6-13) will determine the impact of daily almond butter consumption on gut microbiome composition and function, intestinal barrier integrity, and cardiometabolic health in school-aged children. Participants will be randomized to either a once-daily snack of personalized-portion almond butter (ALB; 16g, Creamy Natural Almond Butter) or an isocaloric nut-free chocolate spread control (CTL; 16g, Cadbury Milk Chocolate), each served on two plain unsalted saltine crackers, added to their habitual diet. The primary outcomes include oro-gut microbial composition and diversity, gut microbial functional capacity and metabolomics (SCFAs, bile acids, amino acid metabolites), and intestinal barrier integrity. Secondary outcomes include fasting cardiometabolic markers, systemic inflammation, appetite-regulatory and metabolic hormones, and sleep-related biomarkers. Feasibility, adherence (weekly logs; serum α-tocopherol), and precision nutrition potential will also be assessed, with stratified analyses by age, sex, BMI, ethnicity, and pubertal stage. This pilot trial will generate the first multi-omics characterization of almond butter's effects on the gut-immune-metabolic axis in children.

Conditions

Dysbiosis; Cardiometabolic Health Indicators

Keywords

gut; gut microbiome; children; pediatric; sleep quality; almonds; nuts; almond butter; metabolomics

Outcome Measures

Primary Outcomes (4)

• Change in Gut Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Fecal Samples

  Freshly voided fecal samples will be collected and DNA extracted using the PowerFecal Pro DNA kit. The V3-V4 hypervariable region of the bacterial 16S ribosomal RNA gene will be PCR-amplified and sequenced. Sequences will be processed using the QIIME2 software package to assess microbial diversity (alpha and beta diversity) and taxonomic composition.

  Baseline (day 0), midpoint (week 4) and endpoint (week 8)

• Change in Oral Microbiome Alpha and Beta Diversity Measured by 16S rRNA Gene Sequencing of Oral Swabs

  Oral biofilm swabs (omniswab - tongue, palate, cheek/lip lining, gums) and unstimulated saliva will be collected in 5ml tubes. DNA will be extracted and the V3-V4 region of the bacterial 16S ribosomal RNA gene PCR-amplified and sequenced. Sequences will be processed using the QIIME2 software package to assess oral microbial diversity (alpha and beta diversity) and taxonomic composition.

  Baseline (day 0) and Endpoint (week 8)

• Change in Fecal Metabolome

  The endpoint of fecal metabolomics will be assessed by collecting fecal samples from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the feces. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular almond butter intake affects metabolic processes and gut health.

  Baseline (day 0) and endpoint (week 8)

• Change in Serum Metabolome

  The endpoint of serum metabolomics will be assessed by collecting blood serum from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the serum. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular almond butter intake affects metabolic processes and gut health.

  Baseline (day 0) and endpoint (week 8)

Secondary Outcomes (17)

• Change in Gut Transit Time

  Baseline (day 0) and endpoint (week 8)

• Change in Waist/Hip Circumference

  Baseline (week 0), midpoint (week 4), and endpoint (week 8)

• Change in Habitual Dietary Intake

  Baseline (day 0), midpoint (week 4), and endpoint (week 8)

• Change in Body Weight

  Baseline (day 0), midpoint (week 4), endpoint (week 8)

• Change in Urinary Melatonin

  Baseline (day 0), midpoint (week 4), and endpoint (week 8)

Study Arms (2)

Almond Butter Condition

EXPERIMENTAL

Participants in the ALB group will maintain their habitual diet supplemented with a once-daily snack of smooth natural almond butter (Creamy Richards 100% Almonds! Creamy Natural Almond Butter) spread between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers), with a maximum of 16g of almond butter per two crackers. The daily portion of almond butter will be individualized to provide 20% of each participant's estimated daily caloric needs, calculated using Dietary Guidelines for Americans (DGA) age- and sex-specific energy requirements.

Other: Creamy Richards 100% Almonds! Creamy Natural Almond Butter

Control Snack Condition

ACTIVE COMPARATOR

Control (CTL) Group: This condition includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread (Cadbury Milk Chocolate) also sandwiched between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers), with the same 16g limit per two crackers. The quantity of chocolate spread provided daily will be equivalent to 20% of each participant's individual daily caloric intake. These caloric needs will be established using Dietary Guidelines for Americans (DGA) based on the participant's age and gender

Other: Cadbury Milk Chocolate Spread

Interventions

Cadbury Milk Chocolate Spread OTHER

Control (CTL) Group: Participants in this group will receive a daily snack consisting of an isocaloric amount of a nut-free, vegetable oil-based chocolate spread ("Cadbury Milk Chocolate") spread between two plain unsalted saltine crackers ("Unsalted Tops Premium Saltine Crackers"). Similar to the peanut butter group, the chocolate spread will be limited to 16g per two crackers, with additional crackers provided if needed.

Also known as: CTL, Isocaloric spread, Control

Control Snack Condition

Creamy Richards 100% Almonds! Creamy Natural Almond Butter OTHER

Almond Butter (ALB) Group: Participants in this group will receive a daily snack consisting of a personalized portion of smooth natural almond butter (Creamy Richards 100% Almonds! Creamy Natural Almond Butter) spread between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers). The amount of almond butter will be limited to 16g per two crackers; additional crackers will be provided if the personalized portion exceeds this limit.

Also known as: ALB, Almond Butter

Almond Butter Condition

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Enrolled in elementary or middle school (grades 1-8)
• Aged 6-13 years old
• Ability to speak and read in English

You may not qualify if:

• Intake of antibiotics in the last 3 months
• Intake of pre/pro/postbiotics in the last 3 months
• Food allergy to study foods
• ◦ Any allergy to nuts or almonds
• Any allergy to the isocaloric snack (chocolate or wheat)
• Regular consumption of nuts or almonds greater than 2 servings / week
• Gastrointestinal disease (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome, irritable bowel syndrome, gastroesophageal reflux disease), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C \> 9%).

Sponsors & Collaborators

• Florida State University: lead
• Almond Board of California: collaborator

Study Sites (1)

The Gut Biome Lab

Tallahassee, Florida, 32306, United States

RECRUITING

Related Links

• Lab Website

MeSH Terms

Conditions

Dysbiosis; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ravinder Nagpal, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rayven Nairn, MS, RD

CONTACT

850-644-1829; rsn25b@fsu.edu

FSU College of Education, Health and Human Services

CONTACT

850-644-1829; healthandhumansciences@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)